7 results
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23ms
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Sources: EU EUDAMED, US FDA
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Country: Ireland
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Alinity i Estradiol Reagent Kit, List Number 07P5020
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i Progesterone Reagent Kit, List Number 08P3620
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i Free T4 Reagent Kit, List Number 07P7030
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i TSH Reagent Kit, List Number 07P4830
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·August 14, 2019